Question 1

Who is the manufacturer of KALTOCARB WOUND DRESSING?

Accepted Answer

Calgon Vestal Div. filed the 510(k) submission for KALTOCARB WOUND DRESSING (K894347).

Question 2

What is the FDA product code for KALTOCARB WOUND DRESSING?

Accepted Answer

FRO. as a Class U device in the SU panel.

Question 3

When was KALTOCARB WOUND DRESSING cleared by the FDA?

Accepted Answer

Aug 23, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for KALTOCARB WOUND DRESSING?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like KALTOCARB WOUND DRESSING?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K894347
Device Name	KALTOCARB WOUND DRESSING
Applicant	Calgon Vestal Div.
Product Code	FRO · SU
Decision Date	Aug 23, 1989
Decision	SESE
Submission Type	Traditional
Device Class	Class U

KALTOCARB WOUND DRESSING

Device Facts